BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTION HYBRID WIRE GUIDE

    MDR report key: 23550473 · Received November 13, 2025

    Report

    Report Number
    3008988055-2025-00014
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Report Date
    November 13, 2025
    Manufacturer
    HERAEUS MEDICAL COMPONENTS LLC
    Product Code
    EZB
    UDI-DI
    00827002448469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY. DEVICE WAS NOT RETURNED TO MANUFACTURER AND THE INVESTIGATION WAS CONCLUDED.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE PHYSICIAN WAS USING A LASER TO TREAT THE STONE. AFTER HE REMOVED ALL OF THE STONE, HE WENT TO PUT IN A BLACK SILICONE STENT. WHEN REMOVING WIRE, AFTER PLACING THE STENT, THE WIRE BROKE INTO SEVERAL PIECES IN THE KIDNEY. THE PHYSICIAN REMOVED EVERYTHING AND THEN WENT BACK IN AND RETRIEVED ALL OF THE WIRE FRAGMENTS WITH A BASKET. THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. ADDITIONAL INFORMATION RECEIVED WHEN DID THE EVENT OCCUR? (PRIOR TO USE, DURING INSERTION, DURING REMOVAL, ETC.) -OBSERVED DURING REMOVAL. PLEASE DESCRIBE THE ACCESS SITE WAS WELL AS THE TARGET LOCATION FOR USE OF THE WIRE. -URETHRA, KIDNEY. DESCRIBE THE PATIENT'S ANATOMY AND DISEASE SEVERITY. (VESSEL, CALCIFICATION, TORTUOSITY, ANGULATION, ETC.)? -URETERAL STRICTURE. WAS THE WIRE ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE? -NO. WHAT IS THE PATIENT'S STATUS OR OUTCOME? -FINE. HAVE ANY KINDS OF INTERVENTION, ADDITIONAL PROCEDURES BEEN PERFORMED? -REMOVAL OF DEVICE FRAGMENTS. WHAT PRE-EXISTING CONDITIONS/CO-MORBIDITIES DID THE PATIENT HAVE? -UNKR. WHAT OTHER MEDICAL DEVICES WERE UTILIZED IN THIS CASE? PLEASE PROVIDE THE MANUFACTURER, BRAND, SIZE, AND PART NUMBER IF POSSIBLE. -COOK DUAL LUMEN CATHETER, 10.7 FLEXOR COOK URETERAL ACCESS SHEATH, SINGLE USE WI FLEXIBLE URETEROSCOPE, LASER FIBER, BLACK SILICONE STENT. WAS THE WIRE ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE? -NO. WAS ANY KINKING OF THE WIRE NOTED? (IF SO, ARE SHARP EDGES PRESENT) -NO. CAN PHOTOS OR VIDEO FROM THE PROCEDURE, (DURING AND/OR AFTER) OR OF THE DEVICE BE PROVIDED? -POSSIBLY. IS THE PATIENT TESTED POSITIVE TO ANY INFECTIOUS DISEASES? -UNKR. DID THE SEPARATION OCCUR DURING PREPARATION? -NO. DID THE SEPARATION OCCUR DURING INSERTION OR REMOVAL? -OBSERVED DURING REMOVAL. WAS ANY PORTION OF THE DEVICE LEFT IN THE PATIENT? -ALL REMOVED WITH A BASKET WAS RESISTANCE ENCOUNTERED DURING INSERTION OR REMOVAL? -MOLTING TEFLON FROM THE BROKEN WIRE CAUSED RESISTANCE AT REMOVAL. WAS THE WIRE BEING REMOVED THROUGH A NEEDLE OR OTHER INSTRUMENT? -NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118723 MOTION HYBRID WIRE GUIDE STYLET FOR CATHETER, GASTRO-UROLOGY EZB HERAEUS MEDICAL COMPONENTS LLC SP-4113-001 9019244136 00827002448469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other